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Numerous private, corporate, community, state, and federal agencies are trying to help stem the tide of HIV among minorities and assist and support outreach and education programs. Federal agencies, in particular can sustain broad prevention, research and education activities.

In its 1992 report, the National AIDS Commission recommended that federal health educators learn and take into account the cultural differences of minorities in order to target prevention messages successfully. CDC is applying this strategy in its new community collaboration and outreach efforts.

"We looked at the whole idea of communities and partnerships and community planning," says Dorothy Triplett, assistant director for Minority and Other Special Populations, Division of HIV/AIDS, CDC. "Community leaders and state and local officials sit at the same tables and are determining what the needs are," she says.

CDC is working with community gatekeepers to change risky behaviors and, she says, CDC also funds national minority organizations and community-based organizations. It has set up initiatives with the Minority Health Professions Foundation, all African American medical schools, and is working with the University of Puerto Rico.

At the National Institutes of Health in Bethesda, Md., which sponsors AIDS clinical trials, officials are extending their efforts to enroll minorities, which have historically been under-represented in trials and treatment studies. According to George W. Counts, M.D., an infectious disease specialist and director of the Office of Research on Minority and Women's Health in NIH's National Institute of Allergy and Infectious Disease (NIAID), it's important to make certain that trial results apply to the minority population, and to make certain that experimental therapies are equally available to minority groups.

To achieve these ends and to provide the best care to trial participants, he says, NIAID aims to ensure equal access to clinical trials and research programs and to dispel mistrust of those programs. Minority enrollments in AIDS clinical trials rose from 17 percent of enrolled subjects in 1988 to 44 percent in 1994.

FDA has developed and maintained numerous research and outreach efforts in the AIDS fight. Says FDA's Mary Beth Jacobs, director, division of life sciences, Center for Devices and Radiological Health, and the center's AIDS coordinator, FDA focused immediately on condoms and their testing and on fast-tracking the new Reality brand female condom as a barrier to virus transmission. A new test method was developed in FDA labs to evaluate barrier effectiveness for condoms and latex gloves. The new Reality brand female condom was fast-tracked for approval.

Elsewhere in the agency, the Center for Drug Evaluation and Research (CDER) actively facilitates the submission of investigational new drug applications, uses treatment INDs and other mechanisms to make drugs available as early as possible, and speeds the approval of AIDS drugs.

"We also send speakers to conferences to explain to researchers, particularly those in minority communities, how to access the FDA," he says. "While we have no minority-specific programs, FDA is making sure that minorities are getting the information about how to get into clinical trials and how to get experimental drugs." For example, a special telephone line (1-800 TRIALSA) provides such information on an ongoing basis.

"We also encourage sponsors to include a diverse population in their clinical trials, but we have no specific regulatory requirement at this time," he says. "In fact, both CDER and the FDA's Office of AIDS and Special Health Issues give information to minority groups and minority physicians about which pharmaceutical companies are doing clinical trials so that minorities can enroll in the trials."

McMaster says that center officials are also studying the issue of pharmacogenetics — that is, the way in which a person's genetic makeup influences the efficacy of a drug and its side effects. The goal is to determine if certain genetic groups may benefit more, or have fewer side effects, when treated with certain classes of drugs. For example, such studies have shown that African Americans respond better to certain classes of antihypertensive drugs than to others. The hope is that similar information could be obtained for AIDS drugs. The agency is also meeting with representatives of other governments at the International Conference on Harmonization to establish a single set of regulations worldwide.

FDA's David Feigal, M.D., division director for antiviral drug production in the center, says that FDA has responded in many ways, including approving 20 different treatments in, "the fastest review time of any group of products the agency has been responsible for."

As for the future? While many researchers and activists brace themselves for the uphill fight ahead, Feigal feels that everyone must be committed for the long haul. We can't wait for a vaccine, he says. Rather, victory will come in little steps, as happened in the national effort to cut the stroke rate among African Americans in the so-called "stroke belt" in the South. "Broad-based community programs took screening and health care into the black communities," he says. "So we need to do much of this with HIV. This won't make the problem go away over night, but we can chip away at it little by little."

Tags: HIV and AIDS

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